NCT03267017

Brief Summary

This prospective study is designed to assess and quantify the correlation between respiratory changes in R-R interval and the respiratory changed in invasive systolic blood pressure in ventilated patients during changes in posture and peak end expiratory pressure (PEEP) and following a fluid bolus

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

August 30, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

August 28, 2017

Last Update Submit

August 29, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Statistical Correlation between respiratory variability of R-R interval and systolic blood pressure

    From immediately after induction of general anesthesia and mechanical ventilation to 20 minutes later

Study Arms (1)

Patient scheduled for surgery under general anesthesia

Other: posture changes

Interventions

Following induction of general anesthesia and initiation of positive pressure ventilation, patients will be tilted 15 degrees head up for 5 minutes with positive end expiratory pressure of 8 cm H2O, and then 15 degrees head down for 5 minutes with positive end expiratory pressure of 3 cm H2O

Patient scheduled for surgery under general anesthesia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study patients

You may qualify if:

  • Age 18-80
  • Scheduled for surgery under general anesthesia requiring invasive blood pressure monitoring

You may not qualify if:

  • Heart Rate other than sinus
  • Cardiac Pacemaker Status
  • Transplanted Heart

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Pediatric Anesthesia

Study Record Dates

First Submitted

August 28, 2017

First Posted

August 30, 2017

Study Start

November 1, 2017

Primary Completion

November 1, 2018

Study Completion

May 1, 2019

Last Updated

August 30, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share